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NCT04445493 Clinical Trial

EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic ( EPISODEPSCOVID )

COVID-19 Clinical Trial

— EPISODE-PH-COV  

Official title:
EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04445493
Other study ID # EPISODE-PH-COVID
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date January 1, 2023

Study information
Verified date November 2022
Source MindRhythm, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prehospital providers encounter patients with suspected stroke frequently. Stroke and COVID-19 are related potentially putting these healthcare workers at risk of COVID-19 infection. In addition, prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers.

Description:

This observational prospective study will document COVID-19 status on patients seen in the prehospital environment for suspected stroke. This will provide an estimate of how frequently stroke occurs in stroke and also the exposure risk to providers in this setting. Additionally, patients will have a headset placed to record their headpulse during the encounter. These measurements will be used to further develop an analytic model used to predict the presence of large vessel occlusion (LVO) stroke. This may help create a device that can be used in the prehospital environment to aid in the trade decision of destination hospital.

Recruitment information / eligibility
Status Completed
Enrollment 486
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - suspected stroke in the prehospital setting - patient at risk for COVID-19 Exclusion Criteria: - scalp laceration - Patient refusal - Prisoner, other vulnerable population - Prehospital provider feels that the recording may interfere with care

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• MindRhythm Harmony
Passive recording of the head pulse

Locations
Country Name City State
United States Wayne State University Detroit Michigan

Sponsors (3)
Lead Sponsor Collaborator
MindRhythm, Inc. Wayne State University, Western Michigan University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smith WS, Keenan KJ, Lovoi PA. A Unique Signature of Cardiac-Induced Cranial Forces During Acute Large Vessel Stroke and Development of a Predictive Model. Neurocrit Care. 2020 Aug;33(1):58-63. doi: 10.1007/s12028-019-00845-x. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of COVID-19 infection in suspected stroke population Through Study Completion, an average of 6 months
Primary Quality head pulse recordings Proportion of head pulse studies deemed of high quality for further analysis Through Study Completion, an average 6 months
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